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The Problem of Substandard Medicines in Developing Countries

The Problem of Substandard Medicines in Developing Countries. By Laura Christian, Linda Collins, Maythiwan Kiatgrajai , Agathe Merle, Nayantara Mukherji , Alissa Quade. Methodology Overview Definitions Harmful Effects Extent of the Problem Framing the Problem Supply Chain Overview

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The Problem of Substandard Medicines in Developing Countries

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  1. The Problem of Substandard Medicines in Developing Countries By Laura Christian, Linda Collins, MaythiwanKiatgrajai, Agathe Merle, NayantaraMukherji, Alissa Quade

  2. Methodology Overview Definitions Harmful Effects Extent of the Problem Framing the Problem Supply Chain Overview Case Studies Manufacturers International Organizations National Governments Recommendations Outline

  3. Methodology • Literature Review to determine scope and extent of the problem • Systematic selection of case studies: • 2 manufacturers: Novartis, Vietnamese manufacturers • 7 international organizations: WHO, UNDP, UNFPA, UNICEF, IFRC, ICRC, MSF • 6 countries: China, India, Thailand, Nigeria, Ghana, Kenya

  4. Substandard medicines: Pharmaceutical products that do not meet quality standards and specifications Made by licensedmanufacturers Arise due to human error, negligence, or resource restrictions Overview: Definitions • Counterfeit medicines: • Products deliberately and fraudulently mislabeled with respect to identity and/or source • Made by non-licensed manufacturers • Arise as a result of illegal activity

  5. Overview: Harmful Effects • At best, ineffective; at worst, deadly • Health effects: • Increased mortality and morbidity • Harmful side effects or allergies • Drug-resistance • Poisoning • Social effects • Political effects • Economic effects

  6. Extent of the Problem • Difficult to assess • Lack of systematic information • Inconsistent definition of substandard • Literature review shows trends • High percentage of substandard medicines in Nigeria, Ghana, Kenya, Indian exports to Africa, and China

  7. Framing the Problem Core problem: while procurers and consumers of medicines have an incentive to buy and consume high-quality products, producers have an incentive to maximize profits Misalignment of incentives produces market and government failures Information asymmetry market failure requires government intervention (regulation) Governments fail to regulate perfectly because they lack sufficient incentives from medicines consumers and suppliers, or from international community

  8. Supply Chain

  9. Manufacturers We used a two-tiered approach to look at manufacturers Large multi-national manufacturers Small manufacturers mainly from developing countries Three main sources Fortune 500 List of Global Pharmaceutical Manufacturers USP Medicine Quality Database Contained over 4,500 samples of medicines Organized by country of sample and country of manufacturer WHO Prequalified Medicines List Two Case studies: Novartis and Manufacturers of Vietnam

  10. Novartis Fortune 500 top pharmaceutical manufacturer 41 billion dollars of revenue in 2009 Produces main anti-malaria medication Found both on WHO PQM and on USP substandard sample (2009 Ghana) Participates actively in production and procurement of anti-malaria medicine from plant grown and harvested in China to production of medicine in the United States Effectively monitors supply chain and sends technical advisors to suppliers Good example of manufacturer monitoring standards

  11. Manufacturers from Vietnam • Manufacturers become a problem because • The transition of the industry from state monopoly to a competitive market • 15-20 % annual growth rate of the pharmaceutical industry • lack of government regulation on quality control • The situation started to get better when the government implemented a policy that forced every local drug manufacturer to meet the WHO’s GMP standards by 2008. • Manufacturers continue to have a problem with the use of unqualified medicine packages

  12. International Organizations • Among the main funders of medicines as humanitarian aid • Oversee medicine delivery in emergency situations • Collaborate to obtain medicine donations • Propose solutions, analyze problems within supply chain, develop methods of collaboration among actors • International organizations are limited in their ability to regulate the spread of substandard drugs

  13. International Organizations Regulations and Safeguards

  14. Long Term Providers • WHO’s Prequalification of Medicines Program (PQP) is followed by many IOs • PQP maintains and updates list of acceptable medicines/laboratories • Main criticism of PQP: too heavily focused on counterfeits • UNDP, UNFPA, and UNICEF are subsidiary  bodies of the United Nations • Heavy focus on transparency • UN funds numerous programs: difficult to keep track of medicine purchases and destinations

  15. Emergency Relief • International Red Cross and Red Crescent Movement (RCRC) • Provide people in conflict areas with basic preventative and curative health care • Share ideas and improve procedures and delivery of medicine • MSF stresses the importance of clarifying the differences between substandard, counterfeit, and generic drugs • MSF believes in the need for tailored solutions

  16. National Governments • Responsible for domestic regulation • Six case studies: China, India, Thailand, Nigeria, Ghana, and Kenya

  17. Substandard medicines in China

  18. Substandard medicines in Nigeria

  19. Recommendations: Policy Goals • Align Incentives • National Governments • Manufacturers • Better Supply Chain Monitoring • Manufacturers • Procurers • Distributors • Clarify Definitions and Increase Emphasis on Substandards

  20. Recommendations: Align Incentives • Incentives for National Government to tighten regulation and enforcement: • Aid and funding to implement GMP and GPP • Ongoing research by WHO • Use of monopsony power • Incentives for manufacturers to self-regulate: • Use existing tools for evaluating manufacturers • Patronize based on transparency • Create competition from developed world

  21. Recommendations: Improved Supply Chain Management • Manufacturers and procurers: • Routine and surprise testing • Communicate dosage, usage, and storage information • Increase transparency • Distributors: • Competitive grants for local organizations and NGOs involved in: • Informing consumers • Implementing awareness campaigns • Publicizing available resources

  22. Recommendations: Clarify Definitions and Emphasize Substandards • Clarify definitions: • Forum to discuss WHO definitions • Follow up: make medical aid conditional on adopting definitions • Emphasize substandards: • Conference for researchers and grant-making foundations • Competitive grants to study substandards independent of counterfeits

  23. Questions?

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